Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting (HIPEOS)
Primary Purpose
Hip Fractures
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EOS imagery
Sponsored by
About this trial
This is an interventional other trial for Hip Fractures
Eligibility Criteria
Inclusion Criteria:
- The patient must have given their free and informed consent and signed the consent form
- The patient must be a member or beneficiary of a health insurance plan
- The patient must be at least 18 years old and less than 85 years old
- Patient has a conventional first intention total hip arthroplasty (not dual mobility) by posterior approach
- "Case" patients have at least one previous episode of prosthetic dislocation repaired with surgery
- "Control" patients have no previous episode of prosthetic dislocation with more than 2 year since initial intervention
Exclusion Criteria:
- The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant, parturient or breastfeeding
- Patient with lumbar instrumentation
- Patient with severe dementia (Mini Mental State Examination < 10)
- Patient with American Society of Anesthesiologists score ≥ 4
- Patient experience multiple falls
- Patient requiring early revision surgery (<15 days postoperatively
- Patient with obvious implant positioning error on an X-ray of the pelvis.
- Patient with dislocation of traumatic origin (significant kinetic trauma)
Sites / Locations
- CHU Lapeyronie de Montpellier
- CHU Nimes
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Patients with previous prothesis instability
Patients without prothesis instability
Arm Description
Outcomes
Primary Outcome Measures
Sacral slope between standing to sitting difference between groups
Sacral slope between standing to sitting difference between groups
Rate of type 1 pelvic kinematic disorder between groups
Measured by sacral slope difference from standing to seated position < 12°.
Secondary Outcome Measures
Lumbar lordosis between standing and seating between groups
degree
Femoroacetabular flexion between standing and seating between groups
degree
Lewinnek plane (Anterior pelvic plane) between standing and seating between groups
degree
Pelvic version between standing and seating between groups
degree
Classification of patients' pelvic kinematic disorder (Type 1 or 2)
Type 1 = Difference in sacral slope between standing and seated position < 12° Type 2 = pelvic version < 20° standing
Classification of patients according to pelvic incidence
Presence/absence
Classification of patients according to sacral slope
Presence/absence
Classification of patients according to sagittal imbalance
Presence/absence of: Sagittal Vertical Axis > 50 mm; Spino-Sacral Angle < 127°
Evolution of acetabular positioning (anteversion and inclination in degree) from standing to sitting
Degree
Full Information
NCT ID
NCT03603470
First Posted
July 2, 2018
Last Updated
August 3, 2020
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT03603470
Brief Title
Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting
Acronym
HIPEOS
Official Title
Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
July 6, 2018 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The authors hypothesize that a pelvic kinematic disorder, demonstrated by a significant decrease in sacral slope, is associated with the risk of instability of total hip prosthesis, the sacral slope being measured by an EOS imaging system during the transition to sitting in unstable patients versus patients with no history of instability.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hip Fractures
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with previous prothesis instability
Arm Type
Other
Arm Title
Patients without prothesis instability
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
EOS imagery
Intervention Description
Whole body EOS imaging in seated and standing position
Primary Outcome Measure Information:
Title
Sacral slope between standing to sitting difference between groups
Description
Sacral slope between standing to sitting difference between groups
Time Frame
Day 0
Title
Rate of type 1 pelvic kinematic disorder between groups
Description
Measured by sacral slope difference from standing to seated position < 12°.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Lumbar lordosis between standing and seating between groups
Description
degree
Time Frame
Day 0
Title
Femoroacetabular flexion between standing and seating between groups
Description
degree
Time Frame
Day 0
Title
Lewinnek plane (Anterior pelvic plane) between standing and seating between groups
Description
degree
Time Frame
Day 0
Title
Pelvic version between standing and seating between groups
Description
degree
Time Frame
Day 0
Title
Classification of patients' pelvic kinematic disorder (Type 1 or 2)
Description
Type 1 = Difference in sacral slope between standing and seated position < 12° Type 2 = pelvic version < 20° standing
Time Frame
Day 0
Title
Classification of patients according to pelvic incidence
Description
Presence/absence
Time Frame
Day 0
Title
Classification of patients according to sacral slope
Description
Presence/absence
Time Frame
Day 0
Title
Classification of patients according to sagittal imbalance
Description
Presence/absence of: Sagittal Vertical Axis > 50 mm; Spino-Sacral Angle < 127°
Time Frame
Day 0
Title
Evolution of acetabular positioning (anteversion and inclination in degree) from standing to sitting
Description
Degree
Time Frame
Day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient must have given their free and informed consent and signed the consent form
The patient must be a member or beneficiary of a health insurance plan
The patient must be at least 18 years old and less than 85 years old
Patient has a conventional first intention total hip arthroplasty (not dual mobility) by posterior approach
"Case" patients have at least one previous episode of prosthetic dislocation repaired with surgery
"Control" patients have no previous episode of prosthetic dislocation with more than 2 year since initial intervention
Exclusion Criteria:
The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
The subject refuses to sign the consent
It is impossible to give the subject informed information
The patient is under safeguard of justice or state guardianship
Patient is pregnant, parturient or breastfeeding
Patient with lumbar instrumentation
Patient with severe dementia (Mini Mental State Examination < 10)
Patient with American Society of Anesthesiologists score ≥ 4
Patient experience multiple falls
Patient requiring early revision surgery (<15 days postoperatively
Patient with obvious implant positioning error on an X-ray of the pelvis.
Patient with dislocation of traumatic origin (significant kinetic trauma)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal Kouyoumdjian, MD
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Lapeyronie de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
12. IPD Sharing Statement
Learn more about this trial
Total Hip Arthroplasty Instability and Lumbo-pelvic Kinematics: EOS Imaging Assessment of Variation in Spinal and Pelvic Parameters From Standing to Sitting
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